Title: Ingredient Review Update from CTFA

The Cosmetic Ingredient Review (CIR) board of the Cosmetic, Toiletry and Fragrance Association (CTFA) announced updated ingredient assessments in its April 4, 2006, report. Anyone who believes a final safety assessment is incorrect may petition the CIR to amend the final safety assessment. Unpublished data cited as references in CIR safety assessments are available for review at the CIR office.

Final Safety Assessments

Cocamidopropylamine oxide was deemed safe in rinse-off cosmetic products in the practices of use and concentration described in the safety assessment; except that the available data are insufficient to support the safety for use in leave-on cosmetic products. *

Drometrizole was considered safe as a cosmetic ingredient in the practices of use and concentration as described in the safety assessment. *

The use of trichloroethane (1,1,1-trichloroethane) as a solvent in cosmetic products is considered as not presenting a direct risk to consumers; however, CIR states this chemical is an ozone-depleting chemical banned by the Environmental Protection Agency for all but essential uses. Since the U.S. Food and Drug Administration (FDA) declared its use in aerosol cosmetics to be non-essential, the result is that this ingredient may not be used in aerosol cosmetics.

Tentative Safety Assessments

Interested persons are given 90 days to comment, provide information, and/or request an oral hearing before the CIR expert panel regarding tentative safety assessments. Information may be submitted without identifying the source or the trade name of the cosmetic product containing the ingredient. All unpublished data submitted to CIR will be discussed in open meetings and are available at the CIR office for review by any interested party. Data submissions are requested by July 6, 2006. These ingredient reports are next scheduled for review by the CIR Expert Panel at its August 14-15, 2006 meeting. Tentative safety assessments are available from the CIR.

2-amino-3-nitrophenol; 2-amino-4-nitrophenol; 2-amino-4-nitrophenol sulfate; 2-amino-5-nitrophenol; 4-amino-2-nitrophenol; 4-amino-3-nitrophenol; 3-nitro-p-hydroxyethylaminophenol; and 4-hydroxypropylamino-3-nitrophenol were deemed safe as hair dye ingredients in the practices of use and concentration as described in the safety assessment; except that the available data are insufficient to support the safety of 4-Amino-2-nitrophenol as a hair dye ingredient.

Polyisobutene and hydrogenated polyisobutene were determined to be safe as cosmetic ingredients in the practices of use and concentration as described in the safety assessment.

Re-reviews

The CIR Expert Panel re-reviewed three ingredient safety assessments previously considered in the 1980s to determine if there is new safety test data. CIR staff compiled the available new information and the panel reviewed the material. In considering sorbic acid and potassium sorbate, the panel noted that the available safety test data in the original safety assessment are likely sufficient to support the safety of sodium sorbate as well.

If a procedure was developed to ensure adequate notice and availability for public comment, CIR concluded it likely would be scientifically correct to include sodium sorbate. The same likely would be true for the steareth group and the addition of higher molecular weight steareth-21, -25, -27, -30, -40, -50, -80 and -100.

The CIR expert panel reviewed the re-review summaries for methylene chloride and the cetearyl alcohol group considered at the December 2005 meeting and offered no suggested changes.

New Data

Benzyl alcohol, benzoic acid and sodium benzoate: In 2000, the CIR expert panel published its final safety assessment of these ingredients concluding that they are safe up to a concentration of 5%, except that there was insufficient data to support their use where inhalation would be a primary route of exposure. Benzyl alcohol was considered safe up to a concentration of 10% in hair dye products. Inhalation toxicity data were needed to resolve the insufficient data conclusion. A four-week inhalation toxicity study of benzoic acid using rats was provided, along with an inhalation toxicity risk assessment. While the CIR expert panel was divided as to the adequacy of the data provided, they agreed that a new draft report should be prepared that incorporates the newly available data, along with any new published data. In the meantime, additional unpublished data or comments that would address the significance of the interstitial fibrosis found that at the lowest dose studied, and the use of lowest observable adverse effect dose, in a risk assessment would be useful. A draft report incorporating the new data will be considered at the Aug. 14-15, 2006, meeting.